pegloticase 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
enzymes	5176	885051-90-1

Description:

Molecule

Description

Synonyms:

methoxypolyethylene glycol uricase
polyethylene glycol-uricase
pegloticase
krystexxa

a recombinant uricase and achieves its therapeutic effect by catalyzing the oxidation of uric acid to allantoin, thereby lowering serum uric acid

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
0.57	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Jan. 8, 2013	EMA	Crealta Pharmaceuticals Ireland Limited
Sept. 14, 2010	FDA	CREALTA PHARMS LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Infusion related reaction	84.67	61.85	27	100	245494	63243401
Therapeutic response decreased	68.08	61.85	17	110	61508	63427387

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Infusion related reaction	557.92	42.98	162	1188	52895	34902686
Therapeutic response decreased	465.24	42.98	124	1226	29189	34926392
Blood uric acid increased	277.84	42.98	66	1284	9558	34946023
Anaphylactic reaction	129.27	42.98	48	1302	32253	34923328
Urticaria	50.91	42.98	31	1319	62346	34893235
Inappropriate schedule of product administration	45.86	42.98	29	1321	62267	34893314
Flushing	45.38	42.98	23	1327	32397	34923184

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Therapeutic response decreased	395.10	37.85	106	1076	66747	79676459
Infusion related reaction	380.16	37.85	137	1045	230100	79513106
Blood uric acid increased	189.35	37.85	43	1139	13317	79729889
Anaphylactic reaction	111.43	37.85	43	1139	83700	79659506
Gout	56.51	37.85	19	1163	24730	79718476
Inappropriate schedule of product administration	48.44	37.85	28	1154	133600	79609606
Flushing	44.44	37.85	23	1159	88245	79654961
Methaemoglobinaemia	38.12	37.85	10	1172	5547	79737659

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	M04AX02	MUSCULO-SKELETAL SYSTEM ANTIGOUT PREPARATIONS ANTIGOUT PREPARATIONS Other antigout preparations
FDA CS	M0022307	Urate Oxidase
FDA EPC	N0000175670	Uric Acid-specific Enzyme

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Gout	indication	90560007	DOID:13189

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

ID	Source
R581OT55EA	UNII
4030213	VANDF
C2350656	UMLSCUI
CHEMBL1237025	ChEMBL_ID
D09316	KEGG_DRUG
DB09208	DRUGBANK_ID
8934	INN_ID
7463	IUPHAR_LIGAND_ID
1011650	RXNORM
177180	MMSL
27504	MMSL
d07688	MMSL
013513	NDDF
449280003	SNOMEDCT_US
765128006	SNOMEDCT_US
C031545	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Krystexxa	HUMAN PRESCRIPTION DRUG LABEL	1	54396-801	INJECTION, SOLUTION	8 mg	INTRAVENOUS	BLA	29 sections
Krystexxa	HUMAN PRESCRIPTION DRUG LABEL	1	75987-080	INJECTION, SOLUTION	8 mg	INTRAVENOUS	BLA	34 sections
Krystexxa	HUMAN PRESCRIPTION DRUG LABEL	1	75987-080	INJECTION, SOLUTION	8 mg	INTRAVENOUS	BLA	34 sections
Krystexxa	HUMAN PRESCRIPTION DRUG LABEL	1	75987-080	INJECTION, SOLUTION	8 mg	INTRAVENOUS	BLA	34 sections